Is Osphena the new wonder drug for better sex?

Osphena (ospemifene) is an oral medication recently approved by the FDA for painful sex (dyspareunia) due to vaginal dryness for menopausal women. As typically happens when a new drug gets FDA approval the PR machine for the company goes into overdrive flooding the media with press releases. Since sex sells, well, Osphena received a fair amount of air time and print space. Headlines like FDA-Approved “Female” Viagra might lead someone to believe that Osphena is freaking amazing. Which, of course, it is not.

What is Osphena? It is an estrogen agonist/antagonist, meaning on some tissues it acts like an estrogen and on other tissues it acts like an anti-estrogen. It acts like estrogen on the vaginal tissues and the lining of the uterus, but it acts like an anti-estrogen on the breast (note; this is in animal studies). There are 3 other drugs on the market in the same class (tamoxifen, toremifene, and raloxifene), however, ospemifene is the only one that works on vaginal tissue.

As estrogen levels drop during menopause (and sometimes a few years before) the vaginal tissues often become fragile and secretions decrease. The vagina may feel dry and sandpaper-like and the tissues may be unable to withstand the friction of intercourse even with a ton of lube. This discomfort is typically treated very effectively with topical estrogen (cream, vaginal tablet, or a ring) which increases secretions and improves the thickness and elasticity of the vaginal tissues. Many women who want to have sex after menopause will need vaginal estrogen, there is just no way around it.

But what about this new drug, Osphena?

First of all, Osphena should only ever be used when the cause of painful sex is low estrogen (the clinical term is atrophy). In other words, this pill is definitely not a Jill of all trades for sexual difficulties.

Secondly, Osphena has a lot of drawbacks and potential problems, many or which are very serious, including the following:

It will stimulate the lining of the uterus and if not prevented this could lead to cancer of the uterus. Women with a uterus will need to take an oral drug called progesterone or a progesterone like drug to prevent this cancer (although a Mirena IUD would also do this).

An increased risk of blood clots

Hot flashes as Osphena as like an antiestrogen on some tissues. Not everyone reports hot flashes, but it is definitely listed as an adverse effect.

Drug interactions.Osphena is metabolized by several liver enzymes that are responsible for the metabolism of other drugs. When two drugs use the same enzyme system side effects and serious adverse reactions are more common. On the flip side, this interaction can also cause a drug to be metabolized so quickly that it becomes less effective. A prescription for Osphena should prompt an review of your medications with a pharamcist.

Vaginal estrogen therapy is the standard of care for pain with sex due to menopausal changes. It is not absorbed to any significant degree and does not affect the lining of the uterus, increase the risk of blood clots, or have drug interactions. With vaginal estrogen women don’t have to take a second medication to prevent uterine cancer. Also, Osphena has not been around very long so there could be unknown long-term side effects.

Osphena has never been studied head-to-head against vaginal estrogen, so while it may be better than placebo no one knows how it might perform against vaginal estrogen. Vaginal estrogen replacement for the majority of women will be the safest option with fewest systemic effects.

Is Osphena the new female Viagra? Not by a long shot. In fact, it seems to be a drug looking for an indication as it is hard to imagine a clinical scenario where Osphena would be the first line treatment for vaginal atrophy.

Dr. Jen, I am having problems with my bladder due to the atrophy of the general area. Vaginal estrogen has not helped. Would osphena help with this situation? I appreciate your frank discussion of the medication; I would be willing to use progesterone to mitigate the cancer risk. Also I was appreciative, that Osphena, being a SERM, might help with my osteopenia. What do you think of its use for these two other medical issues?

I can’t comment on your health or care. Vaginal estrogen helps to reduce bladder infections, this has not been studied for Osphena. Estrogen does not help with incontinence or prolapse so estrogen isn’t typically used for bladder health except to prevent urinary tract infections. Some doctors dose vaginal estrogen too low so the product monograph can offer guidance to compare a prescription to the recommended regimen, however, any women will continue to have infections even with adequate estrogen.

BRAVO!! I agree 100%. I was paid $300 for my opinion (from a marketing research company) on this new oral remedy for vaginal dryness (I disdain the term ‘atrophy’) and I basically told them that there would be a very small subset of women who I would prescribe this medication.
In terms of the ‘female viagra’ claim, this is ludicrous as female sexuality and response is very complicated. Vaginal dryness and dyspareunia is only one component.

You seem very un sympathetic to those of us who have suffered and I do mean SUFFERED, with painful intercourse, due to menopause. In my case it was due to a hysterectomy and vaginal Estrogens never helped. There was one idiot who wanted to send me to a psychiatrist but that was never my problem. It is cruel to let women suffer like this, and it ruins lives. Open your mind, for God’s sake.

I disagree! Speaking for the “subset of women” who are surviving estrogen related breast cancer, post hysterectomy, I am anguished that my loving partner and I have also lost the ability to have comfortable sex due to vaginal atrophy. This Osphena drug could be just what I need to be able to still experience a pain free sex life with my partner.
It bothers me that so many comments I have read have been so dismissive of the very large “subset” that are in the same situation as myself, for which this treatment could add greatly to quality of survival.

Many women who are menopausal and had breast cancer do suffer from painful sex and it should never been discounted as insignificant. However, if you had estrogen related breast cancer then Osphena (given the current body of literature) is unfortunately not recommended. http://www.osphena.com/hcp/p/faqs

I wish that someone would take seriously the distress caused by the loss of libido that many women experience as they age. HRT only goes a small way to countering this, and vaginal estrogen only addresses the local problem of dryness. Damnit, I want to feel sexy again but the general attitude of the medical profession in my experience is to ask whether I’m really still interested in sex at my age (59).

Isn’t that the truth? During a female exam, the doctor asked incredulously, “You’re not still sexually active, are you?” It was embarrassing; of course I am! I’m on my mid 60’s and have taken care of myself, so why shouldn’t I be active? It’s as if doctors have just written us off. With men, however, it’s such a different story.

Well first of all I want to congratulate Shionogi on their very catchy name of their new drug, Osphena. It sounds almost like the name of a greek goddess. No doubt there was a lot of money spent on generating that name.
I used to actually trust the FDA. Unfortunately these days well lets think about this one. There is no proof that it works any better than the current standard treatments AND there could be a risk of cancer if a patient is non compliant. Of course the doctor would prescribe this giving the pt the progesterone like drug if the woman has a uterus but still how many pts might be noncompliant and forget to take it even with all the warnings. Is it worth the risk of getting uterine cancer?

After 12 weeks of using Osphena ….. It does ease the pain of intercourse somewhat …. However it has produced an annoying discharge , it is very costly and it very hard to get to the pills the way they are packaged. I’m not too sure I will continue with it .

I have been taking Osphena for over two months and I have to say it has worked for me. The moisture is back and even the desire. Husband has a big smile. I do not have a uterus so don’t worry about that side effect . The only down side is some nighttime hot flashes. I would say to do your own research and talk with your Doctor about trying this drug.

I have been using Osphena for 7 weeks and have already noticed a big difference. No more pain. Before, I dreaded having sex with my husband because of the pain due to the vulvar atrophy. My gyn would not give me estrogen cream due to my history of breast cancer. She recommended Osphena only because there were no studies indicating that it could cause breast cancer (in animal studies) I realize I am taking a risk, but I feel it is worth it. I am “only” 51 and didn’t want to give up my sex life quite yet.

I had a complete radical hysterectomy at 46 years old, 4 years ago. Sex has been horrific, since. I have been using Osphena for only a week and am thrilled to continue this option. I have been married for 30 years and am not ready to disregard sex. Loss of libido and vaginal atrophy are serious conditions to not only a marriage but serious in general! Estrogen is not an option for me, I was at high risk for ovarian cancer, hence the hysterectomy. Cheers to new meds being created!

Vaginal estrogen does not impact the risk of ovarian cancer. Osphena can stimulate some tissues like estrogen does and so when you take the medication by mouth you expose those Osphena sensitive tissues to that risk.

I have been taking Osphena for 3 months, and am able to have intercourse without pain (actually, my vagina was so ‘atrophied’ intercourse was not even remotely possible). I don’t mind the side-effect of night-time sweating or overheating, but I am concerned about increased sweating during my yoga practice — and I mean INTENSE sweating, so much so that during a hot class I may get chills (from overheating) and have to leave the room. Is this dangerous or just an annoyance? Will it abate? I didn’t experience this at first, which is why I am concerned.

My Gyn. doctor just gave me some samples of Osphena to try, if I wanted go off the vaginal estrogen, and a prescription to use if I like it. I’m wondering why he didn’t give me progesterone with it. Do some doctors not agree on the need of it? Same with the vaginal low dose estrogen. Then I’ve read so many articles online that indicate the need for progesterone with both of these drugs, if you have a uterus. I’ve taken Premarin vaginal estrogen for a couple of weeks now, without progesterone. Is this safe??? I used to take HRT bi-estrogen and natural progesterone made at a compounding pharmacy, until my medical insurance company re-classified it from generic to name brand–and no longer covered it. Just rolling along here with the menopausal changes!

I noticed I have gained about 30 pounds since I have used the Osphena drug over 5 months and constantly experienced hot flashes or sweats. I haven’t changed my eating and did go through gastric bypass so know what I am capable of being able to eat, I have put on the weight since taking the drug. I am going to stop the drug and see if the weight comes back off and may return to Premarin Cream although it is nasty and uncomfortable to use. Weight gain was never mentioned as a side effect but it was mentioned. The people in the commercials are all heavy so their actors are poor and sloppy looking role models to promote the drug. .

I have been taking Osphena for about 3 years. I have loved what it has done for me. And no weight gain at all. Maybe you have something else going on there. And I am so enjoying sex again. I had a few leg cramps initially but drinking more water helped.

Okay, I’m going to take the plunge…throw caution to the wind…and start taking Osphena. I’m about to pop my first pill. I’ll be back in a few weeks to comment (God willing). I LOVE not having periods any more, but terribly miss how things used to be between my hubby and I. My gynecologist just told me that many of her patients have been using Osphena with little or no problems. I’m excited and hopeful about Osphena making things better, but a little nervous, as well.

Good luck with this Ann. I have been on Osphena for almost three years now and have no problems. Early on there were some nighttime hot flashes but they went away. The sex is as good as in my 30’s. The moisture is back and i suspect that my libido is more strong than ever. Husband can’t keep up anymore. And please know that I will be turning 65 soon. Whoo hoo!

Thank you for sharing. That’s good news! I’m three years into menopause and have never had a hot flash, so maybe that won’t happen for me while taking Osphena. I’m encouraged! I hope I tell the same story you do three years down the road. Be well.